Alpelisib - ClinicalTrials.gov

Health-related Quality of Life, Symptom Severity, and Pain Among Patients Treated With Alpelisib for PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study

"Both parts of the study are intended to gather data on HRQoL, disease severity, and pain among patients with PROS who are receiving alpha blockers in the United States. " In addition, patients who have not been treated with alisib will participate in the quantitative portion of the study by supplying statistics on HRQoL, disease severity, and pain gathered from a single administration of the web-based survey. This subset of 15 participants will complete the first online survey one week after the interview to avoid biasing of their survey responses due to their interview experience. ".

Source link: https://clinicaltrials.gov/ct2/show/NCT05294289

SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast): A Phase 2 Study on Fulvestrant Beyond Progression in Combination With Alpelisib for PIK3CA-mutated, Hormone-receptor Positive HER2 Negative Advanced Breast Cancer

"In the current phase two research, we will investigate the safety of the combination of fulvestrant and alpelisib specifically after its implementation in patients with a PIK3CA mutated breast cancer patients with PIK3CA mutated tumors. " As the new treatment option, eligible patients must have progressive disease on fulvestrant. All participants will be treated with alpha and fulvestrant beyond progression after study enrollment.

Source link: https://clinicaltrials.gov/ct2/show/NCT05392608

EPIK-P2: A Phase II Double-blind Study With an Upfront, 16-week Randomized, Placebo-controlled Period, to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

"British only the participants of Group 1 and Group 2 will be registered as part of the study. " Participants who were randomized to receive placebo will be moved to active treatment with alisib after Week 16. Those people who were randomized to receive alisib will continue their active treatment. Participants in Group 4 will be registered before Group 3 of Group 4's participants will be confirmed. Participants in Groups 1 and 2 will be included later, after the primary research's results, the efficacy, safety, and PK results, as well as Group 4's numbers, will be available from the participants in Groups 1 and 2, in order to select the appropriate dose for participants in Group 3. The planned duration of alisib therapy in the study will be up to five years after randomization/treatment started for all age groups.

Source link: https://clinicaltrials.gov/ct2/show/NCT04589650

EPIK-B5: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With HR-positive, HER2-negative Advanced Breast Cancer With a PIK3CA Mutation, Who Progressed on or After Aromatase Inhibitor and a CDK4/6 Inhibitor

"British research will recommend alletisib plus fulvestrant or alpelisib-matching placebo plus fulvestrant will be launched on Cycle 1 Day 1 on Cycle 1; as per BIRC's report, the introduction of new antineoplastic therapy, death, failure to follow-up, or withdrawal of consent. Participants in the alpelisib-matching placebo plus fullvestrant arm with disease progression per RECIST v1. 1 as determined by the BIRC will have the opportunity to cross over to be treated with alludevestrant alpha.

Source link: https://clinicaltrials.gov/ct2/show/NCT05038735

EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

"Part 1 is the open-label, safety run-in part of the study, designed to announce the recommended phase 3 dose of alisib in combination with trastuzumab and pertuzumab. ".

Source link: https://clinicaltrials.gov/ct2/show/NCT04208178

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